Effects of Progressive Muscle Relaxation and Mindfulness Meditation in Patients With Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

Effects of Progressive Muscle Relaxation and Mindfulness Meditation on Dyspnea, Fatigue and Care Dependency in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04301700
• Other study ID #: 2408
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: April 20, 2020

Study information

• Verified date: March 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with COPD will be entered. Participants will be randomized to one of three study arms: Arm 1: meditation; Arm 2: relaxation; Arm 3: Control. Hypothesis: Progressive muscle relaxation and mindfulness meditation will decrease severity of dyspnea, fatigue and care dependency.

Description:

Previous reports have revealed that progressive muscle relaxation and meditation are decreasing symptoms burden in chronic disease. On the other hand, no study has been conducted to determine the effects of progressive relaxation exercise and mindfulness meditation on dyspnea, fatigue and care dependency in patients with COPD. The present study investigates the effects of progressive muscle relaxation and mindfulness meditation in a single-site, 3-arm, assessor-blinded randomized, controlled study of 65 COPD patients. Arm 1: meditation; Arm 2: relaxation; Arm 3: Control.The investigators hypothesize that Progressive muscle relaxation and mindfulness meditation will decrease the severity of dyspnea, fatigue and care dependency.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: April 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• older than 40 years

• diagnosed with stage III-IV COPD

• had at least primary school degree

• had no cognitive dysfunction, or communication problems

• were residing in Ankara.

Exclusion Criteria:

• history of cognitive dysfunction, or communication problems

• illiteracy

• applying any complementary and integrative approach during the study

• participating in a pulmonary rehabilitation program during the study.

Related Conditions & MeSH terms

• COPD
• Fatigue
• Lung Diseases, Obstructive
• Mediation
• Pulmonary Disease, Chronic Obstructive
• Signs and Symptoms
• Symptoms and Signs

Intervention

Behavioral:
• mindfullness and relaxation
three arms: mindfullness and relaxation

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dyspnea	The Dyspnea-12 Scale	Baseline
Primary	Change in dyspnea	Dyspnea will be measured by The Dyspnea-12 Scale. The range of total score was from 0 to 36, with higher scores demonstrating higher dyspnea level.	Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
Primary	Change in fatigue	Quality of live will be measured by Asthma Fatigue Scale (CAFS). The CAFS scores is standardized to 0-100 in line with the following formula, (100 × (total score-minimum value to be obtained)/range), with higher scores indicating greater fatigue.	Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
Primary	Change in care dependency	Quality of live will be measured by Care Dependency Scale (CDS). The sum of the scores changes from 17 to 85, with higher scores demonstrating lower dependence.	Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions